MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0469-01C
Medical Device Problem Codes	Optical Problem (3001); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after several hours of intra-aortic balloon (iab) therapy, a fiber optic sensor failure occurred and the pressure could not be obtained.However, therapy was continued.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Event site postal code: (b)(6).The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id#: (b)(4).
Additional Manufacturer Narrative
The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id # (b)(4).
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).

• Brand Name: SENSATION 7FR. 34CC IAB
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 16015210
• Report Number: 2248146-2022-00993
• Device Sequence Number: 20666279
• Product Code: DSP
• UDI-Device Identifier: 10607567109367
• UDI-Public: 10607567109367
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2024
• Device Model Number: 0684-00-0469-01C
• Device Catalogue Number: 0684-00-0433
• Device Lot Number: 3000164243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 11/16/2023; 11/30/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 11/22/2023; 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown